Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level
NCT ID: NCT04677244
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2021-11-11
2025-11-01
Brief Summary
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Detailed Description
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In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:
* the level of circulating tumor cells (CTC) per milliliter of blood,
* cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).
A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.
Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Portal vein blood sample
Blood sample in portal vein
A 6 ml blood sample will be taken from the portal vein, before and after the echo-endoscopic biopsy of the pancreatic mass. The second sample will be taken after the biopsy if there is no bile drainage, or after bile drainage if indicated. The delay between the end of the biopsy procedure and the puncture will be 5 minutes. A 6 ml peripheral blood sample will also be taken before and after the endoscopic procedure.
Interventions
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Blood sample in portal vein
A 6 ml blood sample will be taken from the portal vein, before and after the echo-endoscopic biopsy of the pancreatic mass. The second sample will be taken after the biopsy if there is no bile drainage, or after bile drainage if indicated. The delay between the end of the biopsy procedure and the puncture will be 5 minutes. A 6 ml peripheral blood sample will also be taken before and after the endoscopic procedure.
Eligibility Criteria
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Inclusion Criteria
* BMI\< 30 kg/m2;
* Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
* Affiliation to, or beneficiary of, a social security scheme.
Exclusion Criteria
* Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
* Biliary drainage or attempt at prior biliary drainage outside the center ;
* Preliminary oncological treatment for pancreatic pathology covered by the study;
* Clinical and/or image-visible (CT/MRI) carcinosis ;
* Ascites visible on imaging (CT/MRI) ;
* Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons;
* Contraindications to an endoscopic procedure.
40 Years
85 Years
ALL
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Fabrice CAILLOL, MD
Role: PRINCIPAL_INVESTIGATOR
Paoli Calmettes Institute
Locations
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Institut Paoli Calmettes
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EUS-CTC-IPC 2019-056
Identifier Type: -
Identifier Source: org_study_id
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